Celcuity Inc. — Third Quarter 2026 Earnings Summary

Financial Performance:

• Net loss for the third quarter of 2026 was $73.3 million ($1.33 per share), compared to a net loss of $43.8 million ($0.92 per share) in the prior year period.
• Non-GAAP adjusted net loss for the third quarter of 2026 was $66.8 million ($1.21 per share), compared to $37.2 million ($0.78 per share) in the prior year period.
• Total operating expenses were $77.3 million for the third quarter of 2026, an increase from $42.8 million in the prior year period.
• Research and development expenses were $37.5 million for the third quarter of 2026, up from $30.4 million in the prior year period.
• Selling, general and administrative expenses were $39.8 million for the third quarter of 2026, up from $12.4 million in the prior year period.
• Net cash used in operating activities was $66.2 million for the third quarter of 2026, compared to $44.8 million in the prior year period.
• Cash, cash equivalents, and short-term investments totaled $642.7 million at the end of the third quarter of 2026.
• No product revenue was recognized in the third quarter of 2026 as shipments of REVTORPYK commenced on September 30, 2026, with revenue recognition occurring upon delivery.
• A $50.0 million payment to Pfizer was made during the quarter, triggered by receipt of FDA approval for REVTORPYK.
• Convertible notes increased to $753.958 million at September 30, 2026, from $195.324 million at December 31, 2025.
• Total liabilities increased to $800.908 million at September 30, 2026, from $366.003 million at December 31, 2025.
• Stockholders' equity (deficit) was $(74.039) million at September 30, 2026, compared to $100.555 million at December 31, 2025.

Guidance and Future Outlook:

• Management expects current cash, cash equivalents, and short-term investments to finance operations through 2029.
• Celcuity expects to submit VIKTORIA-1 Phase 3 data for both wild-type and mutant cohorts to global regulatory authorities later in 2026 or early 2027.
• The randomized Phase 2 study evaluating gedatolisib in combination with darolutamide for prostate cancer is expected to begin in the first half of 2027.

Business Segments and Product Lines:

• REVTORPYK (gedatolisib) became commercially available on September 30, 2026, for the treatment of HR+/HER2- locally advanced or metastatic breast cancer without a PIK3CA mutation following progression on or after at least one line of endocrine therapy.
• 91% of U.S. commercial and Medicare lives are covered by health plans that include REVTORPYK.
• 78% of the top 36 strategic accounts, representing approximately 50% of the total addressable patient population, have prescribed REVTORPYK.
• Over 3,400 sites have engaged with Celcuity oncology sales specialists, treating 82% of breast cancer patients.
• REVTORPYK has been incorporated into 3 of the 4 largest health care provider pathways.
• Updated Phase 3 VIKTORIA-1 results for the PIK3CA mutant cohort showed median progression-free survival of 21.5 months for the gedatolisib triplet and 11.5 months for the doublet, versus 9.1 months for alpelisib + fulvestrant in patients with no liver metastases.
• Objective response rates for the VIKTORIA-1 mutant cohort were 59% (triplet) and 43% (doublet), compared to 33% for alpelisib + fulvestrant.
• Celcuity submitted a supplemental New Drug Application (sNDA) to the FDA in the third quarter of 2026 for the PIK3CA mutant cohort.
• Enrollment is ongoing in the Phase 3 VIKTORIA-2 clinical trial for first-line treatment of HR+/HER2- advanced breast cancer.
• Updated Phase 1b/2 data for metastatic castration-resistant prostate cancer (mCRPC) showed a median radiographic progression-free survival of 15.7 months in patients with prior abiraterone exposure and 9.1 months in patients with prior enzalutamide exposure.

Market and Competitive Landscape:

• The NCCN included REVTORPYK as a preferred Category 1 recommendation for second-line and/or subsequent-line therapy for HR+/HER2- advanced breast cancer without a PIK3CA mutation.
• The company cites unprecedented efficacy results from the wild-type cohort of the VIKTORIA-1 study as a compelling value proposition.
• Management notes physicians are enthusiastic and eager to treat eligible patients with REVTORPYK.

Risks and Challenges:

• Forward-looking statements note risks including potential changes to clinical trial data following comprehensive review, unforeseen delays in clinical trials or FDA review, and the ability to obtain regulatory approval for the sNDA and maintain U.S. approvals.
• Risks include the ability to obtain regulatory approval for gedatolisib outside the U.S. and market acceptance of REVTORPYK.
• Potential competition from the development of other therapies and tools exists.
• Risks include the company's ability to access capital on favorable terms.

Management Commentary and Tone:

• CEO Brian Sullivan stated that commercial and medical affairs teams have laid a foundation for a strong launch and that efforts are paying off.
• Management expressed pleasure with physician interest in getting eligible patients on treatment in the initial weeks since launch.
• The tone regarding the launch is positive, citing early engagement from over 1,100 healthcare providers attending educational programs.

Other Key Points:

• Byron Robinson, Ph.D., J.D., joined Celcuity as Chief Strategy Officer.
• Celcuity's balance sheet includes $1.476 million in inventory as of September 30, 2026, compared to zero at December 31, 2025.
• Intangible assets increased to $50 million at September 30, 2026, from zero at December 31, 2025.
• The company reported a loss on debt extinguishment of $11.477 million for the nine months ended September 30, 2026.
• A live webcast and conference call were hosted on November 5, 2026.